Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities

Published by Nature Reviews Neurology

Biomarker DiscoveryResearch and Drug Development Disease or Translational Resource BiomarkerPain Therapeutic BiomarkerChronic PainBiomarker ValidationRegulatory Issue

This article outlined the NIH initiative, Helping to End Addiction Long-term (HEAL). A trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to provide guidance on biomarker discovery and rigorous validation to accelerate high-quality clinical research into neurotherapeutics and pain.

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The Biomarker Commercialization (BIC) Guide supports academic researchers and SMEs when developing an in-vitro diagnostic biomarker invention to a commercial product. It provides guidance through the technology readiness levels (TRL) and covers the clinical, regulatory, and business aspects of the commercialization process. The tasks are described and partially supported by useful, downloadable documents.

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